The study of acute toxicity of the topical combination with glucosamine and ketoprofen in the form of a cream-gel
Keywords:topical combination, glucosamine, ketoprofen, acute toxicity, cutaneous application, intragastric administration
Safety of new drugs is the most important criteria for the study, and it is determined by the analysis of acute toxicity. When determining acute toxicity the adverse effects of drugs are described in their single use or multiple administrations in a short period of time.
Aim. To determine the toxicity class of a new topical combination containing 5.0 % glucosamine hydrochloride and 2.0 % in the form of a cream-gel or cutaneous application and intragastric introduction.
Materials and methods. The studies were carried out in accordance with EC Directive 86/609 EEC. The cutaneous application of the combination was in the range of doses from 43 to 22600 mg/kg. The object studied was used in the dose range from 500 to 5000 mg/kg in intragastric introduction. The behavior of animals and their survival were observed within 14 days.
Results. During the observation after cutaneous application there was no mortality, changes in the common life cycle of rats and the skin irritation. In intragastric introduction of the combination its LD50 was higher than 5000 mg/kg.Conclusions. Therefore, the study of acute toxicity of the combination has shown the absence of mortality in rats at the maximum allowable doses for cutaneous application and intragastric introduction. This fact indicates a low toxicity of the G/K cream-gel, and it gives the possibility to refer the combination studied to the category of relatively harmless substances.
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